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mRNA Process Development

mRNA Process Development

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IVT RNA

mRNA Process Development

The Importance of mRNA Process Development
  • Circular plasmid DNA (pDNA), as the starting material, should be completely linearized to produce a defined length RNA transcript.
  • As a common synthesis strategy for RNA molecules, in vitro transcription (IVT) allows us to obtain customized transcripts efficiently. IVT is a complex reaction requiring a mixture of DNA template, RNA polymerase, RNase inhibitor, inorganic pyrophosphatase, co-factors, unmodified or modified nucleoside triphosphates (NTPs), and buffer to produce mRNA transcripts. The ideal RNA yield cannot be achieved with a single solution, as it is contingent upon various reaction factors Additionally, the IVT reaction may be sequence-dependent.
  • After the IVT reaction, the product- and process-related impurities (e.g., dsRNA, truncated RNA fragments, DNA template, NTPs, and RNA polymerase) should be removed to obtain pure mRNA as an active pharmaceutical ingredient (API).
mRNA Process Solutions of Yaohai Bio-Pharma

Our available general mRNA process development services include:

  • Linear plasmid process development and optimization
  • IVT process development and optimization
  • mRNA purification process development and optimization
Methodology

Quality by Design (QbD)

Design of Experience (DoE)

One Factor at a Time (OFAT)

Service Details
Service Details Unit Operations Parameters
Single-enzyme Digestion Digestion reaction Reaction components, volume, rotational speed
Linearized DNA Purification IEX, Anion or cation exchange chromatography Types of chromatography resin/column Buffer composition, Mobile phase composition, pH, Flow rate, binding, washing and elution conditions.
RPC, Reversed phase chromatography
mRNA Synthesis by IVT IVT reaction IVT reaction components, volume, rotational speed, IVT time
DNA removal DNase concentration
Enzymatic Capping Capping reaction Reaction components, volume, rotational speed
mRNA Purification AC, Affinity chromatography Several types of chromatography resin/column (e.g., AC, IEX, RPC, SEC, MMC), Buffer composition, injection volume, Mobile phase composition (adsorption and desorption), pH, flow rate, binding, washing, and elution conditions.
IEX, Anion, or cation exchange chromatography
SEC, Desalting, and/or size exclusion chromatography
RPC, Reversed-phase chromatography
MMC, Mixed mode chromatography
Tangential flow filtration Membrane material and pore size, feed flow rate, transmembrane pressure (TMP), filtrate volume to membrane area ratio
Timeline of mRNA CDMO Solutions

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